ABOUT PLATELET-RICH FIBRIN MATRIX

SELPHYL® PRFM is utilized by physicians in their practices for various applications. The process is simple and the entire procedure takes approximately 20 minutes. While it may be possible to achieve your desired results after just one treatment, additional treatments are generally recommended. Your doctor will determine the best approach for you individually.

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WHAT IS THE SELPHYL® PRFM SYSTEM?

The SELPHYL® System is designed for the safe and rapid preparation of Platelet-rich Fibrin Matrix (PRFM) from a small sample of blood at the patient point of care. Many PRP systems require operator skill, have varying results and have extensive contamination with red blood cells and white blood cells. SELPHYL® removes virtually all contaminating cells and is independent of operator technique. PRP is converted to PRFM through a controlled process, creating a scaffold that serves to protect and preserve platelets.

 

Think of SELPHYL® PRFM as the next generation PRP.

The Power of Platelets

Platelets and other components in human blood migrate to a site of injury. Platelets are known to release a variety of growth factors that respond to tissue injury, where they initiate and promote healing. By concentrating platelets at the site of injury, physicians have the potential to enhance the body’s natural capacity for healing.

The Key Advantages & Benefits

Include:

  • SUPERIOR TECHNOLOGY

  • VISUAL GUIDE TO QUALITY

  • COMPLETELY CLOSED SYSTEM

  • ULTRAPURE PRFM

  • OPERATOR INDEPENDENT

  • FIBRIN MATRIX SCAFFOLD

  • VIABLE PLATELETS

  • SUSTAINED PLATELET GROWTH FACTOR RELEASE FOR DAYS

  • EXTENSIVE SAFETY PROFILE

  • OVER 150K PATIENTS TREATED

NEXT GENERATION PRP

PRP vs. PRFM

PRP

PRFM

  • Platelets in plasma

  • Activation is immediate

  • Alpha granules release growth factors quickly (bolus)

  • Short-term tissue signaling

  • Minutes – hours

  • Platelets in fibrin matrix

  • CaCl2 binds to Na Citrate 1:1

  • Clotting cascade resumes (Fibrinogen – Fibrin)

  • Platelets remain viable with controlled GF release

  • Hours – days

WHAT IS THE REGULATORY STATUS OF THE SELPHYL® SYSTEM?

The SELPHYL® System was cleared for marketing in 510(k) premarket notification number BK170096. Factor Medical, Inc. markets the Autologous Fibrin & Platelet System in this 510(k) under the trade names SELPHYL® and PRFM.

CAUTION: United States Federal law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to, by or on the order of a physician.

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The SELPHYL® System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics.

SELPHYL®

940 Town Center Drive

Suite F-20

Langhorne, PA 19047

1.877.SELPHYL

Factor Medical Inc.

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